A Phase 2 interventional study of PL9643 Ophthalmic Solution and Placebo Ophthalmic Solution in Dry Eye Disease, sponsored by ORA, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by ORA, Inc. · Phase 2, Interventional, and Treatment
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.
During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →ORA, Inc. is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
vehicle
Drug: Placebo Ophthalmic Solution
PL9643 Ophthalmic Solution
Drug: PL9643 Ophthalmic Solution
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time frame: Day 85
Ocular Discomfort Using The Ora Calibra Scale
A patient-reported subjective assessment of ocular discomfort using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale recorded at each study visit throughout the treatment period
Time frame: Day 85
Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time frame: 12 weeks
Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
An assessment of conjunctival lissamine green staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time frame: 12 weeks
Conjunctival Redness Using The Ora Calibra Scale
An assessment of conjunctival redness using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time frame: 12 weeks
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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ORA, Inc.